Mumbai, April 7 -- Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: i) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and ii) as an adjunct to diet and exercise to improve glycemic control in adult...
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